Hemodynamic Effects of Rolofylline in the Treatment of Patients With Heart Failure (7418-503)

This study has been completed.
NovaCardia, Inc.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
First received: August 5, 2008
Last updated: October 19, 2015
Last verified: October 2015
The study will estimate the effects of rolofylline, alone and in addition to loop diuretic therapy on pulmonary capillary wedge pressure and other hemodynamic parameters, in patients with heart failure and renal impairment.

Condition Intervention Phase
Heart Failure
Drug: Comparator: Placebo
Drug: rolofylline
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Hemodynamic Effects of Rolofylline Injectable Emulsion in the Treatment of Patients With Heart Failure

Resource links provided by NLM:

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • change in pulmonary capillary wedge pressure [ Time Frame: from baseline to 4 and 8 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in cardiac output, systemic vascular resistance, pulmonary vascular resistance, pulmonary pressure and right atrial pressure [ Time Frame: from baseline to 4 and 8 hours ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: November 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
Drug: Comparator: Placebo
rolofylline placebo IV infusion over 4 hours.
Experimental: 2
Drug: rolofylline
rolofylline 30 mg IV infusion over 4 hours.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with heart failure and renal impairment, currently using furosemide, with systolic blood pressure >95 mm Hg

Exclusion Criteria:

  • Patient has active infection, use of diuretic within 3 hours of screening visit, has acute tubular necrosis or severe pulmonary disease, any heart problems within the last two weeks
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00729222

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
NovaCardia, Inc.
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00729222     History of Changes
Other Study ID Numbers: 7418-503  MK7418-503  2008_532 
Study First Received: August 5, 2008
Last Updated: October 19, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases
Cardiovascular Agents
Natriuretic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on April 27, 2016